Completed
Double Blind Placebo Controlled Dose Ranging Study for the Assessment of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Multiple Ascending Oral Doses of GLPG0778 in Healthy Male Subjects
What is being tested
GLPG0778
+ placebo
Drug
Who is being recruted
From 18 to 50 Years
+6 Eligibility Criteria
How is the trial designed
Placebo-ControlledPhase 1
Interventional
Study Start: April 2011
Summary
Principal SponsorGalapagos NV
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: April 1, 2011
Actual date on which the first participant was enrolled.The purpose of the study is to evaluate the safety and tolerability of multiple ascending oral doses (MAD) of GLPG0778 given to healthy subjects for 13 days compared to placebo, and to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of GLPG0778 after multiple oral administrations.
Principal SponsorGalapagos NV
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
45 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Male
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
2 inclusion criteria required to participate
healthy male, age 18-50 years
body mass index (BMI) between 18-30 kg/m², inclusive.
4 exclusion criteria prevent from participating
significantly abnormal platelet function or coagulopathy
smoking
drug or alcohol abuse
hypersensitivity to any of the test substances
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
2 intervention groups are designated in this study
50% chance of being blinded to the placebo group
Treatment Groups
Group I
ExperimentalMultiple ascending doses for 13 days, ranging from 50 mg twice daily upto a maximum to be determined during escalation.
Group II
PlaceboTwice daily for 13 days, matching the scheme of the multiple ascending dose.
Study Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center